Description
Responsibilities include but not limited to:- Development and writing of clinical trial protocols
- Design of case report forms (CRFs)
- Preparation of study management documents such as the Monitoring Plan, study procedural manuals, and Laboratory Manuals
- Development of informed consent forms, patient diaries and other study related documents
- Management of study related supplies
- Coordination of study related meetings
- Identification and assessment of the suitability of vendors to be used as part of study conduct
- Oversight of performance of vendors
- Oversight of clinical trial sites
- QC of study related documentation
- Review of study related data and metrics
- Set-up and conduct of investigator meetings
- Identification of potential investigators
- Set-up and maintenance Trial Master File (TMF)
- Management of clinical trial materials/investigational product
- Archiving study documentation and correspondence
Skills & Education Required:
- BS/?BA degree in a life science, RN, or related field
- Able to work effectively in a small team environment, with cross-functional team members, and external vendors
- Excellent written and verbal communication and interpersonal skills
- Able to produce accurate work to tight deadlines within a pressured environment
- Proficiency in MS Word, Excel and Powerpoint
- 3+ ?years of relevant clinical experience in a CRO, pharmaceutical or biotechnology company
- Experience in antivirals and/or pediatrics an advantage
To find out more about Real please visit www.realstaffing.com